Image-Guided Transurethral HIFU for Genitourinary Therapy

 描述(由申请人提供)：女性压力性尿失禁(SUI)是盆底顺应性的增加，导致尿路压力下降，通常是通过分娩，并在劳作时表现为尿漏。穗对女性的健康有重大影响，包括与抑郁症水平的增加有关。治疗选择仅限于侵入性手术插入胶带植入物，这限制了尿路的流动性。在尿路周围组织内注射膨胀剂是一种长期有效但暂时的治疗方法。药物相对较新，价格高得令人望而却步，而且没有长期疗效的记录。剩下的1400万女性只能通过戴吸收垫或尿布来缓解病情。临床上需要一种非侵入性的方法来替代传统的外科手术方法，同时保证较低的发病率。 和恢复时间、更快的手术时间和更低的成本。最近对微创热疗技术的临床研究表明，对组织进行有针对性的热疗可以减轻SUI的症状。这些技术显示出了希望，但它们比目前的手术选择更具侵入性，而且效果较差。治疗性和间质性超声设备是我们团队正在开发的一项创新技术，用于提供治疗癌症和子宫肌瘤的热疗，具有证明的能力 提供对选择性加热模式的动态空间控制、更大的径向热渗透率和更快的治疗时间。我们建议开发这项专门用于治疗SUI的超声技术；该技术有可能为治疗SUI提供一种卓越的微创加热技术，承诺更准确和彻底的靶向，保护关键的非靶向组织(例如，尿路、阴道壁)，更容易接触到更多的SUI患者，以及更快的手术时间。这项第一阶段研究计划的目标是扩展现有技术并开发专门用于成功治疗SUI所需的特定组织结构的选择性和适形热疗的经尿道治疗性超声波敷贴器。实验设计、台架实验、生物热学和声学模拟，以及在体外组织中的实验测试和在老年母羊体内的先导研究将用于设计反馈和表征设备性能，以及评估技术和潜在的临床可行性。这些结果将用于开发和了解改进的设备和潜在的治疗方法，为第二阶段的产品开发和临床实施的最终目标做准备。

 DESCRIPTION (provided by applicant): Stress urinary incontinence (SUI) in women is an increase of pelvic floor compliance which results in decrease of urethral pressure, typically through childbirth, and presents as urine leakage during exertion. SUI has significant impact on women's health, including an association with increased levels of depression. Curative options are limited to the invasive surgical insertion of a tape implant which limits the mobility of the urethra. Bulking agents injected in the peri-urethral tissue are a longstanding effective but temporary treatment. Pharmaceuticals are relatively new, prohibitively expensive, and there is no track record of long term efficacy. The remaining 14 million women are relegated to the palliative approaches of wearing absorptive pads or diapers. A substantial clinical need exists for a noninvasive alternative to traditional surgical approaches with the promise of less morbidity and recovery time, faster procedure time, and lower cost. Recent clinical investigations of minimally-invasive thermal techniques have demonstrated targeted thermal modification of tissue can reduce symptoms of SUI. These techniques have shown promise, but are more invasive than the current surgical options and are less effective. Therapeutic and interstitial ultrasound devices are an innovative technology under development by our group for delivering thermal therapy for treating cancer, as well as uterine fibroids, with demonstrated capabilities to provide dynamic spatial control of selective heating patterns, greater radial thermal penetration, and fast treatment times. We propose to develop this ultrasound technology specifically for the treatment of SUI; this technology has potential to provide a superior minimally-invasive heating technique for treating SUI with the promise of more accurate and thorough targeting, protection of critical non-targeted tissue (e.g., urethra, vaginal wall), more accessibility to a larger numbe of SUI patients, and faster procedure times. The objective of this Phase I research plan is to extend existing technology and develop transurethral therapeutic ultrasound applicators specific for selective and conformal thermal therapy of specific tissue structures required for successful treatment of SUI. Empirical design, bench experiments, biothermal and acoustic modeling, together with experimental testing in both ex-vivo tissues and a pilot in-vivo study in older ewes GU tract will be used for design feedback and to characterize device performance, as well as assess the technical and potential clinical feasibility. These results will be applied to the development and understanding of refined devices and potential treatment approaches in preparation for the ultimate goal of product development and clinical implementation during Phase II.